candesartan cilexetil, tablets, 16 mg, 90-count bottles, Rx only, Manufactured for Sandoz Inc., Princeton, NJ 08540 by Mylan Laboratories Limited Hyderabad, 500 034, India, NDC 0781-5938-92
Reported: December 10, 2014 Initiated: October 2, 2014 #D-0288-2015
Product Description
candesartan cilexetil, tablets, 16 mg, 90-count bottles, Rx only, Manufactured for Sandoz Inc., Princeton, NJ 08540 by Mylan Laboratories Limited Hyderabad, 500 034, India, NDC 0781-5938-92
Reason for Recall
Failed Impurities/Degradation Specifications: An Out of Specification (OOS) result was generated for the 18 month stability time point for ketone cilexetil impurity and total impurities.
Details
- Recalling Firm
- Sandoz, Inc
- Units Affected
- 6,336 bottles
- Distribution
- Nationwide
- Location
- Princeton, NJ
Frequently Asked Questions
What product was recalled? ▼
candesartan cilexetil, tablets, 16 mg, 90-count bottles, Rx only, Manufactured for Sandoz Inc., Princeton, NJ 08540 by Mylan Laboratories Limited Hyderabad, 500 034, India, NDC 0781-5938-92. Recalled by Sandoz, Inc. Units affected: 6,336 bottles.
Why was this product recalled? ▼
Failed Impurities/Degradation Specifications: An Out of Specification (OOS) result was generated for the 18 month stability time point for ketone cilexetil impurity and total impurities.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on December 10, 2014. Severity: Low. Recall number: D-0288-2015.
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